Brief Title
Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy
Official Title
Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study
Brief Summary
to show that
1. patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory
function
2. use of rivastigmine has a positive effect on apathy in PSP patients
3. therapy with rivastigmine has a no positive benefit on speech and overall results of the
MMST
4. changes in motor activity are associated with changes in language and overall results of
the in MMST
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"
Secondary Outcome
changes in speech function and improvement of quality of life
Condition
Progressive Supranuclear Palsy
Intervention
rivastigmine
Study Arms / Comparison Groups
1
Description: patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
February 2008
Completion Date
February 2010
Primary Completion Date
December 2009
Eligibility Criteria
Inclusion Criteria:
- diagnosis of PSP
- willingness to participate in the study
- informed consent
- ability to speak
- no further CNS diseases
- written informed consent
- stable state of health
- ability to give informed consent, will checked by an independent physician
Exclusion Criteria:
- alcohol abuses
- acute psychosis
- pregnancy or lactation
- known previous drug reaction or hypersensitivity of rivastigmine or other carbamate
derivatives
- liver failure
- known sick sinus syndrome or excitation disturbance
- known ulcus ventriculi or duodenal ulcer
- known asthma or COPD
- seizures
- renal failure
Gender
All
Ages
50 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Daniela Berg, Doctor, +49 7071 29 80438, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00522015
Organization ID
RIVA
Secondary IDs
eudraCT no: 2006-006166-42
Study Sponsor
University Hospital Tuebingen
Study Sponsor
Daniela Berg, Doctor, Principal Investigator, University Hospital Tuebingen
Verification Date
August 2007